Korean J Psychopharmacol.  2008 Jul;19(4):197-208.

The Efficacy and Safety of Olanzapine Monotherapy in Patients with Acute Bipolar Mania: A Multi-Center, Open-Label Trial

• Yoon BH
• Bahk WM
• Lee SY
• Lee JG
• Chung SK
• Park SH
• Jon DI
• Woo YS
• Bae SO
• Min KJ

Abstract

OBJECTIVE
Although atypical antipsychotics are increasingly being used as monotherapy in acute mania, few Korean studies have investigated on them. This study evaluated the efficacy and tolerability of olanzapine monotherapy in patients with acute mania.
METHODS
This multicenter, open-label study evaluated the efficacy of olanzapine to treat mania over 6 weeks. Patients with a DSM-IV diagnosis of bipolar I disorder (manic or mixed episodes) were treated with olanzapine (flexible dosage to a maximum of 30 mg/day). Clinical improvements were rated using the Young Mania Rating Scale (YMRS), Clinical Global Impression-Bipolar Version (CGI-BP), Brief Psychiatric Rating Scale (BPRS), and the Montgomery-Asberg Depression Rating Scale (MADRS). Adverse events were measured using the Simpson-Angus Rating Scale (SARS) and Barnes Akathisia Rating Scale (BARS). The general functioning of patients was assessed using the Global Assessment Scale (GAS). All assessments were carried out at baseline and at days 7, 14, 21, and 42, with the exception of the GAS.
RESULTS
The subjects comprised 76 patients (male=38, female=38), with 55 patients (72.4%) completing the study. The mean initial dose of olanzapine was 11.7+/-5.0 mg/day and mean daily doses at days 7, 14, 21, and 42 were 16.6+/-5.2, 17.2+/-5.0, 18.1+/-5.3, and 17.4+/-4.7 mg/day, respectively. At days 7, 14, 21, and 42, YMRS, CGI-BP, MADRS and BPRS scores had significantly improved from baseline. More improvement in MADRS scores was observed among patients with mixed mania than patients with euphoric mania. Changes in BPRS scores from baseline did not differ between patients with psychotic symptoms and those with euphoric mania. At days 21 and 42, 42 (55.3%) and 57 (75.0%) patients had responded (YMRS scores decreased from baseline by more than 50%). Also 27 (35.5%) and 46 (60.5%) patients had achieved remission (YMRS scores < or =12) at the same assessment points. GAS scores at days 21 and 42 indicated that olanzapine monotherapy improved patients' global functioning compared to baseline. SARS and BARS scores did not differ significantly between pre- and post-drug trial.
CONCLUSION
The data indicate that olanzapine monotherapy has favorable effects across a broad range of mood symptoms and yields functional improvement in acute manic patients with minimal adverse events. Therefore, olanzapine monotherapy may be a preferred first-line agent to treat patients with acute mania. These results support the findings from previous studies and guidelines.

Keyword

Acute mania; Olanzapine monotherapy; Efficacy; Safety

MeSH Terms

Antipsychotic Agents
Benzodiazepines
Bipolar Disorder
Brief Psychiatric Rating Scale
Depression
Diagnostic and Statistical Manual of Mental Disorders
Humans
Psychomotor Agitation
Antipsychotic Agents
Benzodiazepines